timdarpacept (IMM01) / ImmuneOnco Biopharma - LARVOL DELTA

Humanized Monoclonal Antibody IMM47, Targeting CD24, Exhibits Exceptional Anti-Tumor Efficacy By Blocking the CD24/Siglec-10 Interaction and Can be Used As Monotherapy or in Combination with Anti-PD1 Antibodies for Cancer Immunotherapy (ASH 2023) - "IMM47 monotherapy or in combination with SIRP-Fc fusion protein (IMM01) or anti-PD-1 antibodies were used to test IMM47's anti-tumor efficacy in SCID mice with Jeko-1 or MCF-7 tumor cell xenotransplantation and hPD-1 Tg C57BL/6 mice with MC38-hCD24/hPD-L1 tumor cell homologous transplantation models...Additionally, an in vivo pharmacodynamics assay of IMM47 in combination with different PD-1 antibodies revealed that IMM47 exhibits synergistic therapeutic efficacy when combined with Tislelizumab, Opdivo, and Keytruda. Our research showed that the humanized anti-CD24 mAb IMM47 had excellent anti-tumor effect. The extracellular domain's N-glycosylation alteration has no effect on IMM47's ability to bind to CD24. The in vitro assays revealed that IMM47 exhibits significant ADCC, ADCP, ADCT, and CDC activities."

Clinical • Combination therapy • IO biomarker • Monotherapy • Oncology • CD24 • PD-L1 • SIRPA

IMM01 Plus Tislelizumab in Prior Anti-PD-1 Failed Classic Hodgkin Lymphoma: An Open Label, Multicenter, Phase 2 Study (IMM01-04) Evaluating Safety As Well As Preliminary Anti-Tumor Activity (ASH 2023) - "IMM01-04 showed a robust anti-tumor effectivity with a well-tolerated safety profile in prior anti-PD-1 failed classical Hodgkin Lymphoma patients. The phase 2 study is ongoing."

Clinical • P2 data • Anemia • Classical Hodgkin Lymphoma • Head and Neck Cancer • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lung Cancer • Lymphoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • SIRPA

Preliminary Results of a Phase 2 Study of IMM01 Combined with Azacitidine (AZA) As the First-Line Treatment in Adult Patients with Chronic Myelomonocytic Leukemia (CMML) (ASH 2023) - P1/2 | "Preliminary data showed that IMM01 (without a low-dose priming) combined with AZA were well tolerated. The combo, when compared to the historical data of AZA alone, showed exciting efficacy result for patients with treatment-naive CMML1-2."

Clinical • P2 data • Acute Myelogenous Leukemia • Anemia • Chronic Myelomonocytic Leukemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • SIRPA

Preliminary Results of a Phase 2 Study of IMM01 Combined with Azacitidine (AZA) As the First-Line Treatment in Adult Patients with Higher Risk Myelodysplastic Syndromes (MDS) (ASH 2023) - P1/2 | "Preliminary data from IMM01 (without low-dose priming) combined with AZA were well tolerated and showed exciting efficacy results in patients with treatment-naive higher-risk MDS."

Clinical • P2 data • Tumor mutational burden • Anemia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • ASXL1 • DNMT3A • SIRPA • TMB • TP53 • U2AF1

…The first patient has been successfully dosed in the Phase IB/II clinical trial of IMM2510 in combination with IMM01 for the treatment of advance solid tumors (HKEXnews)

Trial status • Solid Tumor

A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=104 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P1/2 trial • Solid Tumor

A Study Evaluating the Stability and Efficacy of IMC-001 for Injection on Atherosclerotic Plaques in Patients With ACS. (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | N=14 ➔ 30 | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Nov 2025 ➔ Jun 2026

Enrollment change • Trial completion date • Trial primary completion date • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: ImmuneOncia Therapeutics Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2027 ➔ Aug 2029 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Solid Tumor

A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

Updated results of a phase 2 study: Timdarpacept (IMM01) combined with azacitidine (AZA) as the first-line treatment in adults with chronic myelomonocytic leukemia (CMML). (ASCO 2025) - P1/2 | "Timdarpacept, without a low-dose priming, combined with AZA, was well tolerated in 1L CMML. The combination, when compared to the historical data of AZA monotherapy, showed promising efficacy results for patients with treatment-naive CMML-1 and -2."

Clinical • P2 data • Anemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • SIRPA

Updated efficacy and safety results from the phase 2 study of timdarpacept in combination with tislelizumab in patients with classical Hodgkin lymphoma for whom prior anti–PD-1 therapy failed. (ASCO 2025) - P1b/2 | "Funded by No funding sources reported Clinical Trial Registration Number: NCT05833984 Background: Timdarpacept (IMM01), a recombinant SIRPa-Fc fusion protein, can activate macrophages to enhance anti-tumor activity by blocking CD47-SIRPa interaction. Timdarpacept in combination with tislelizumab showed promising therapeutic efficacy and a well-tolerated safety profile in cHL patients for whom anti-PD-1 failed, providing evidence for future investigation."

Clinical • Combination therapy • P2 data • Anemia • Classical Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • SIRPA • TNFRSF8

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. | Trial primary completion date: Oct 2026 ➔ Apr 2026

Trial primary completion date • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

APPROVAL BY THE NMPA FOR CLINICAL TRIAL OF IMM01 (TIMDARPACEPT) COMBINED WITH IMM2510 (PALVERAFUSP α) AND WITH OR WITHOUT CHEMOTHERAPY FOR ADVANCED MALIGNANT TUMORS (HKEXnews) - "The board (the 'Board') of directors ('Directors', and each a 'Director') of the Company is pleased to announce that the Group has received approval from the National Medical Products Administration of the People’s Republic of China (the 'NMPA') for a clinical trial of IMM01 (Timdarpacept) in combination with IMM2510 (palverafusp α) and with or without chemotherapy, for the treatment of advanced malignant tumors."

New trial • Solid Tumor

A Study of IMC-001 on Improved Atherosclerotic Plaque Stability in Patients of ACS (clinicaltrials.gov) - P2 | N=14 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P2 trial • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular

ImmuneOnco's Phase Ib/II clinical study application for IMM2510 combined with IMM01 has been accepted by the National Medical Products Administration (NMPA) | Project Progress [Google translation] (bydrug.pharmcube.com) - "On December 16, 2024, ImmuneOnco Biopharmaceutical Technology (Shanghai) Co., Ltd. ('ImmuneOnco', Hong Kong Stock Exchange stock code: 01541.HK) announced that the Phase Ib/II clinical research application (IND) for the PD-L1xVEGF bispecific antibody IMM2510 combined with Timdarpacept (IMM01) was accepted by the National Medical Products Administration (NMPA)....Currently, it has entered Phase Ib/II clinical research for further development in multiple solid tumor indications, both as a monotherapy and in combination with different treatment modes."

New P1/2 trial • Solid Tumor

IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2) (clinicaltrials.gov) - P3 | N=170 | Recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Combination therapy • New P3 trial • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

DNp73 enhances tumor progression and immune evasion in multiple myeloma by targeting the MYC and MYCN pathways. (PubMed, Front Immunol) - "Blockade of the CD47/SIRPα and PD-1/PD-L1 signaling pathways by the SIRPα-Fc fusion protein IMM01 and monoclonal antibody atezolizumab significantly restored the anti-MM activity of macrophages and T cells in the microenvironment, respectively. Moreover, our study clarified that DNp73 overexpression not only promotes aggressive growth of tumor cells but, more importantly, promotes immune escape of MM cells through upregulation of immune checkpoints. DNp73 could serve as a biomarker for immunotherapy targeting PD-L1 and CD47 blockade in MM patients."

IO biomarker • Journal • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • CD47 • CDK7 • MYC • MYCN • SIRPA

Efficacy and safety of a phase II study: Timdarpacept (IMM01) combined with azacitidine (AZA) as the first-line treatment in adults with chronic myelomonocytic leukemia (CMML) (ESMO 2024) - P1/2 | "Timdarpacept, without a low-dose priming, combined with AZA, was well tolerated in 1L CMML. The combination, when compared to the historical data of AZA monotherapy, showed exciting efficacy results for patients with treatment-naive CMML-1 and -2."

Clinical • P2 data • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • SIRPA

Efficacy and safety results from the phase II study of Timdarpacept in combination with tislelizumab, in prior anti-PD-1 failed classical Hodgkin lymphoma (ESMO 2024) - P1b/2 | "Background: Timdarpacept (IMM01), a recombinant SIRPa-Fc fusion protein, can activate macrophages to enhance anti-tumor activity by blocking CD47-SIRPa interaction. Timdarpacept in combination with tislelizumab showed a robust therapeutic efficacy with a well-tolerated safety profile in anti-PD-1 failed cHL patients. The study is ongoing to further evaluate secondary endpoints."

Clinical • Combination therapy • P2 data • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • SIRPA • TNFRSF8

ORPHAN-DRUG DESIGNATION FROM FDA IN RESPECT OF COMBINATION OF IMM01 AND AZACITIDINE FOR THE TREATMENT OF CMML (ImmuneOnco Press Release) - "...Food and Drug Administration of the United States (FDA) has granted an orphan-drug designation to IMM01 in combination with azacitidine for the treatment of chronic myelomonocyte leukemia (CMML)."

Orphan drug • Chronic Myelomonocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

First Patient In and Dosing completed in Phase III Clinical Trial of Timdarpacept (IMM01) combined with Tislelizumab for cHL patient refractory to PD-(L)1 therapy (ImmuneOnco Press Release) - "...Timdarpacept (IMM01) combined with Tislelizumab for refractory cHL Phase III clinical trial successfully completed the first patient enrollment on July 1, 2024."

Enrollment status • Hematological Malignancies • Hodgkin Lymphoma • Oncology

Combining CD38 antibody with CD47 blockade is a promising strategy for treating hematologic malignancies expressing CD38. (PubMed, Front Immunol) - "The CD38/CD47 BsAbs had a greater ability to block the CD47/SIRPα signal in CD38+/CD47+ tumor cells than IMM01 (SIRPα Fc fusion protein)...A panel of BsAbs targeting CD38 and CD47 developed based on the "mAb-tarp" platform showed potent tumor-killing ability in vitro and in vivo. As BsAbs had lower affinity for binding to CD47, higher affinity for binding to CD38, no affinity for binding to RBCs, and did not induce RBC agglutination, we concluded that CD38/CD47 BsAbs are safe and have a satisfactory tolerability profile."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD47 • SIRPA

A Study of IMM01 in Combiniation With Tiselizumab Versus Physician's Choice Chemotherapy in PD-(L)1-refractory Classical Hodgkin Lymphoma (clinicaltrials.gov) - P3 | N=202 | Not yet recruiting | Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

New P3 trial • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology

Timdarpacept (IMM01) in combination with tislelizumab in prior anti-PD-1 failed classical Hodgkin lymphoma: An open label, multicenter, phase II study (IMM01-04) evaluating safety as well as preliminary anti-tumor activity. (ASCO 2024) - P1b/2 | "IMM01-04 showed a robust anti-tumor effectivity with a well-tolerated safety profile in prior anti-PD-1 failed cHL patients. The phase II study is ongoing."

Clinical • Combination therapy • P2 data • Anemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • SIRPA • TNFRSF8

Latest results of a phase 2 study of IMM01 combined with azacitidine (AZA) as the first-line treatment in adults with higher risk myelodysplastic syndromes (MDS). (ASCO 2024) - P1/2 | "IMM01 (without low-dose priming) combined with AZA were well tolerated and showed exciting efficacy results in patients with treatment-naive higher-risk MDS."

Clinical • P2 data • Anemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Myelodysplastic Syndrome • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Thrombocytopenia • Transplantation • ASXL1 • DNMT3A • NPM1 • RUNX1 • SIRPA • U2AF1